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Laboratory Informatics CSV Business Analyst

Valspec
Napa, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

 

CSV BUSINESS ANALYST - LAB SYSTEMS
(DIGITAL GxP LABORATORY INFORMATICS SYSTEMS)


SUMMARY

The Lab Systems CSV Business Analyst will develop a strategy for laboratory digital systems qualification and validation in a cGMP biopharma manufacturing environment. Provide qualification and validation leadership for all digital technologies surrounding laboratory informatics.

The role will collaborate and partner with the key business stakeholders across IT and Operations Technology groups to include but not limited to: Analytical Development, Process Development, Quality Control, Data Science, Automation, Manufacturing Science & Technology and Computer Systems Validation.

As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the Lab Systems CSV BA will be involved in computer systems validation for LIMS, ELN, and Data Systems (to include backup/restore/archive). Will be instrumental in developing and managing GxP lifecycle documentation, including Validation Plans, Specifications, Testing Protocols (IQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports. 


REQUIREMENTS

  • 8+ years' experience of Computer System Validation (CSV) experience within the life sciences industry, including validation of LIMS (LabWare, LabVantage, SampleManager).
  • Diverse experience across a multitude of Lab GxP systems such as Laboratory Informatics (LIMS), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Lab System Data Recovery.
  • Experience creating validation master plans and performing risk assessments.
  • Direct experience developing validation protocols and execution of protocols.
  • Knowledge of current industry standards such as GAMP5 and ASTM E2500.
  • Passionate about leading and mentoring others.
  • Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
  • Excellent client communication skills.

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

Valspec

Address

Napa, CA
USA

Industry

Healthcare

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